Varixio: A New Foam Sclerotherapy Device in Europe

VARIXIO is an innovative medical device recently introduced to markets in Europe, South America, and Japan. This highly-versatile device enables the preparation of standardized and high-quality microfoam using commonly-used sclerosing agents with air and physiological gases. It is the first automated foam preparation device available globally, outside of the U.S. Developed and marketed by Vascular Barcelona Devices (VB Devices), a Barcelona-based start-up, VARIXIO represents a new generation in sclerotherapy. The company aims to position VARIXIO as the "global reference for foam sclerotherapy," according to Dr. Enric Roche, one of the co-founders of VB Devices. In this article, we delve into Dr. Roche's background, his journey in founding VB Devices, and what the future holds for this cutting-edge technology.

Vein Magazine: Tell us about your background as a vascular surgeon.

Dr. Enric Roche: I have been a vascular surgeon in Spain for over 25 years. While I have had the fortune of experiencing the versatility and breadth of indications that this specialty has to offer, I early on had the chance to create a team that was intensively dedicated to phlebology, and this is an area I’ve specialized in particular. My group at Hospital Platon in Barcelona was among the early adopters in Spain of the endovenous approach techniques, as well as endo laser and RF, and I was one of the first to carry out phlebectomy procedures by trans-illumination (Trivex), and more recently MOCA with Clarivein and Flebogrif.

VM: How did you become involved with sclerotherapy?

ER: In 2003 I had the chance to invite Dr. Lorenzo Tessari to our hospital, where we had the pleasure of hosting one of the first sclerotherapy workshops in Spain. Building on what we learned then, we developed our own experience, gradually increasing the role of sclerotherapy in our practice.

VM: What impact did the adoption of this technique have on your practice?

ER: Increased use gradually showed us the versatility of this technique, revealing what the use of sclerosing microfoam could mean for the treatment of varicose veins of all sizes and locations. I was convinced then that foam sclerotherapy would play a crucial role in modern phlebology.

VM: What was the driver behind the invention of VARIXIO? What problem were you trying to solve?

ER: My initial experience with foam sclerotherapy convinced me of the technique's potential to make minimally invasive procedures the norm in phlebology. However, I felt manual foam preparation methods, while somewhat satisfactory, were limiting the approach's potential. On the one hand, I felt it was difficult to consistently obtain a high-quality foam that was stable, irrespective of sclerosant concentration or gas type. Secondly, the use of physiological gases with the Tessari method was cumbersome. I felt automation could potentially address these limitations, so I set out to explore it.

VM: How did the concept behind the device materialize?

We started in 2013 by visiting several manufacturers of lab equipment, as well as research centers, and discussing our needs. The brainstorming that ensued led to the first prototypes where we discovered we could prepare high-quality foam even at low concentrations of sclerosant, using both room air as well as an O2CO2 gas mixture. Interestingly, different speeds and times of agitation led to different foam qualities.

VM: It's been quite a while since that first prototype.

ER: Indeed! After working for about a year with that first prototype, I convinced myself it could be turned into a product. We proceeded to patent the invention and presented the first results around the properties of the foam prepared with our prototype at the European Venous Forum (EVF), in Paris, in 2014. Further convinced by the feedback we received at the EVF, in terms of what a device with this versatility could mean for the increased adoption of foam sclerotherapy, we set out to turn the prototype into a medical device.

VM: Easier said than done…

ER: Absolutely! I was toying with several other ideas then, including two devices to support endovascular techniques, but realized I needed help to go beyond filing patents and testing prototypes. I was lucky then to come across Federico Grego, an economist with entrepreneurial and general management experience in the biomedical sector. We worked together for some time exploring ways forward for the foamer prototype and the other devices and soon realized we needed to raise funds, start a company, and professionalize the project, with the right team and suppliers around it if we wanted to move forward. I still had my day job seeing patients – so time was slipping!

VM:The start of an adventure…

ER: For sure! We founded Vascular Barcelona Devices, “VB Devices,” in October of 2016; we closed a first funding round among friends and family of approximately $500k, which got us on our way, with a primary focus on the former device, today “VARIXIO.”

VM: Can you describe the development process at a high level?

ER: Yes. I would break it down into three steps:

  1. 1) the development of the VARIXIO Pod, which is the sterile, single-use component in which the foam is prepared
  2. the development of the VARIXIO Pro Mag, which is the pre-programmed magnetic stirrer on which the VARIXIO Pod is placed to prepare the foam
  3. the definition of the appropriate stirring programs to ensure high-quality foam in all circumstances.

Throughout the whole process, we also had to generate the documentation needed to support the quality and regulatory certifications required for product approval. The latter is something I completely underestimated going into the project but it is a decisive success factor.

We set out to define a long list of product specifications that set the prototype apart from what we intended to be a marketable medical device, including considerations around sterility, safety, ease of use, and industrial scalability, among others while retaining the flexibility of allowing physicians to consistently obtain high-quality foam while using different sclerosants, sclerosant concentrations, and types of gas.

Hundreds of experiments and tens of prototypes followed. We came across several important challenges that we thought would be showstoppers, but finally, after close to three years of work, we had fully functional prototypes that met all the target specifications.

With the final prototypes, we conducted extensive testing, supported by external research centers, to determine the right stirring programs (time and speed) to consistently give us the foam we wanted, with full flexibility in terms of sclerosant, concentration, and gas type.

VM: What are the characteristics of foam prepared with the VARIXIO device?

ER: It’s a dense, highly stable foam with a homogeneous bubble size in the range of 100 microns and a liquid-to-gas ratio between 1:5 and 1:7. Importantly, we know we can adjust the stirring parameters on VARIXIO Pro Mag to target very specific foam characteristics. The process by which we set the device’s initial parameters we published in Phlebology in 2020.

VM: How would you summarize VARIXIO’s contribution to the treatment of varicose veins?

ER: As a vascular surgeon and an expert in phlebology, I believe that VARIXIO breaks down barriers for foam sclerotherapy that will allow bringing the benefits of this safe, effective, and minimally invasive treatment to all types of patients while adding convenience for physicians. The versatility that comes with preparing high-quality foam with polidocanol or STS, even from low concentrations, using sterile air or a mix of physiological gases, opens the door to treating any type of varicose vein with foam sclerotherapy.

VM: Where is VARIXIO marketed to date, and what has been user feedback?

ER: We first launched VARIXIO in Spain in early 2021. From there, we have expanded across Europe and have also launched in Japan and several Latin American countries. More than 300 clinics are using VARIXIO, and user feedback is unanimously very positive.

Importantly we are starting to see new users contribute their experience in congresses and publications, most notably highlighting the device's versatility
and what it means in terms of new applications for foam sclerotherapy.

VM: Curious, how did you wind up launching in Japan?

ER: We were contacted by Medico’s Hirata, a local company specializing in the vascular space. Medico’s Hirata introduced the first-ever Aortic stent graft in Japan in 2006 and started the importation and commercialization of Thrombectomy devices for acute stroke in 2011.

They were interested in distributing VARIXIO in Japan. After assessing the market opportunity and regulatory pathway, we decided to work with them to launch VARIXIO there. It was launched officially in July 2022 at the 42nd annual meeting of the Japanese Society of Phlebology in Tokyo. As in other markets, the feedback has been very positive.

VM: Do you have plans for the U.S.?

ER: Yes. We see a big opportunity for VARIXIO in the U.S. We feel VARIXIO can bring simplification and ease of use versus existing alternatives while eventually broadening indications for foam sclerotherapy with standardized, high-quality, low-nitrogen microfoam. We have been working hard with a team of regulatory and market access experts to determine the right path to access the market while consulting with local opinion leaders to ensure we shape the product to meet local requirements and preferences. We are pressing forward with our plans, including identifying the right commercial partner.

VM: Finally, how do you combine the role of a vascular surgeon with that of an entrepreneur?

ER: Undoubtedly, it’s a big effort and one that I perhaps would not have undertaken if someone had told me what it was truly going to entail. No weekends, late nights, sometimes sleepless nights… However, the excitement of overcoming challenges, seeing progress, seeing the smiles on the faces of colleagues when showing them prototypes, and the possibility of making a small contribution to the advancement of our specialty has been a constant drive to push forward.